NCT06084234 National Liver Cancer Screening Trial
| NCT ID | NCT06084234 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University of Texas Southwestern Medical Center |
| Condition | Carcinoma, Hepatocellular |
| Study Type | INTERVENTIONAL |
| Enrollment | 5,500 participants |
| Start Date | 2023-12-26 |
| Primary Completion | 2029-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 5,500 participants in total. It began in 2023-12-26 with a primary completion date of 2029-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The National Liver Cancer Screening Trial is an adaptive randomized phase IV Trial comparing ultrasound-based versus biomarker-based screening in 5500 patients with cirrhosis from any etiology or patients with chronic hepatitis B infection. Eligible patients will be randomized in a 1:1 fashion to Arm A using semi-annual ultrasound and AFP-based screening or Arm B using semi-annual screening using GALAD alone. Randomization will be stratified by sex, enrolling site, Child Pugh class (A vs. B), and HCC etiology (viral vs. non-viral). Patients will be recruited from 15 sites (mix of tertiary care and large community health systems) over a 3-year period, and the primary endpoint of the phase IV trial, reduction in late-stage HCC, will be assessed after 5.5 years.
Eligibility Criteria
Inclusion Criteria: Patient must meet all of the following inclusion criteria: 1. Adult patients ages 18-85 with cirrhosis from any etiology or with chronic hepatitis B with a PAGE-B score greater than 9 within 12 months of enrollment 2. Patient is eligible for HCC surveillance according to treating physician or by the site investigator 3. Able to provide informed consent 4. Life expectancy \>6 months (after consent) as determined by the treating provider or site investigator Exclusion Criteria: Patient will be excluded for any of the following exclusion criteria: 1. Child Pugh C cirrhosis 2. History or clinical symptoms of hepatocellular carcinoma or cholangiocarcinoma 3. History of solid nodule on baseline ultrasound (i.e., lesion 1cm or greater) within 9 months prior to consent without subsequent diagnostic CT/MRI demonstrating benign nature) 4. AFP \>20 ng/mL within 6 months prior to consent, in the absence of a contrast-enhanced CT or MRI within 6 months of AFP (before or after) level demonstrating lack of suspicious liver lesions 5. Newly diagnosed LR-3 greater than or equal to 1 cm within 6 months prior to consent 6. History of LR-4, LR-5, or LR-M on multi-phase CT or contrast-enhanced MRI within 6 months prior to consent 7. Presence of another active cancer besides non-melanomatous skin cancer or indolent cancer under active surveillance (e.g., prostate cancer or renal cell carcinoma) within the 2 years prior to consent 8. Patient's provider is planning to use MRI- or CT- based surveillance moving forward 9. History of a transjugular intrahepatic portosystemic shunt (TIPS) 10. History of Fontan associated liver disease or cardiac cirrhosis 11. History of solid organ transplantation 12. Actively listed for liver transplantation 13. Diagnosis of alcohol-associated hepatitis within 3 months prior to consent 14. Documented current or continued signs and symptoms of acute Wilson disease (acute liver failure, acute neurological deficits, hemolysis) 15. In patients with primary sclerosing cholangitis (PSC): Current active cholangitis within 90 days prior to consent 16. Known or documented habitual non-adherence to previous research studies or medical procedures or unwillingness to adhere to protocol (e.g., unwilling to obtain consent or samples) 17. In patients living with HIV: CD4+ T cell count less than 100 cells/mm3 within 60 days prior to consent 18. Known pregnancy at consent 19. Active warfarin use
Contact & Investigator
Amit Singal, MD, MS
PRINCIPAL INVESTIGATOR
University of Texas Southwestern Medical Center
Frequently Asked Questions
Who can join the NCT06084234 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Carcinoma, Hepatocellular. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06084234 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06084234 currently recruiting?
Yes, NCT06084234 is actively recruiting participants. Contact the research team at Amit.Singal@UTSouthwestern.edu for enrollment information.
Where is the NCT06084234 trial being conducted?
This trial is being conducted at Los Angeles, United States, Redwood City, United States, Roseville, United States, San Francisco, United States and 11 additional locations.
Who is sponsoring the NCT06084234 clinical trial?
NCT06084234 is sponsored by University of Texas Southwestern Medical Center. The principal investigator is Amit Singal, MD, MS at University of Texas Southwestern Medical Center. The trial plans to enroll 5,500 participants.